Hadn't noticed there is a US (IDE) specific study for IDE AND a separate EU specific study for CE approval, per your link to clinicaltrials.gov per below. Why two separate clinical investigations?
Only CE study is listed as recruiting.
Have the FDA and BSI both concluded they need their own clinical data to support approval? Is this due to differences in standard of care?
Only EU (CE) study is recruiting all at UK and Aus sites it appears. Though the data may not be accurate and was not updated since August. And interesting that 40 participants are being enrolled in the EU CE approval study, per your link, with completion due Feb 2020 ...
The US study states 20 participants.
Have I misinterpreted the PRs to date?
That 14 of 20 participants are recruited in the IDE Study? That these participants can also be used for CE approval? That CE approval is pending?
It's all very confusing ...
Any update pending to the clinicaltrials.gov website?
Or any clarification on the need for 2 separate studies with 40 participants required for the one study that is actually recruiting?
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